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Temsirolimus, Carboplatin, and Paclitaxel as First-Line Therapy in Treating Patients With Newly Diagnosed Stage III-IV Clear Cell Ovarian Cancer

NCT01196429 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2019-08-08

Study results available
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Summary

This phase II trial studies how well temsirolimus, carboplatin, and paclitaxel as first-line therapy works in treating patients with newly diagnosed stage III-IV clear cell ovarian cancer. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving temsirolimus with combination chemotherapy may be an effective treatment for ovarian cancer.

Conditions

  • Ovarian Clear Cell Cystadenocarcinoma
  • Stage III Ovarian Cancer
  • Stage IV Ovarian Cancer

Interventions

DRUG

Carboplatin

Given IV

DRUG

Docetaxel

Given IV

OTHER

Laboratory Biomarker Analysis

Correlative studies

DRUG

Paclitaxel

Given IV

DRUG

Temsirolimus

Given IV

Sponsors & Collaborators

  • NRG Oncology

    collaborator OTHER

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • John Farley · NRG Oncology

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2015-01-31
Completion
2015-01-31

Countries

  • United States
  • Japan
  • South Korea

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01196429 on ClinicalTrials.gov